U.S. patent number 8,469,977 [Application Number 12/785,268] was granted by the patent office on 2013-06-25 for endoscopic plication device and method.
This patent grant is currently assigned to Barosense, Inc.. The grantee listed for this patent is Daniel J. Balbierz, Dave Cole, Samuel T. Crews, John Lunsford, Fiona Sander, Andrew Smith, Brett Swope. Invention is credited to Daniel J. Balbierz, Dave Cole, Samuel T. Crews, John Lunsford, Fiona Sander, Andrew Smith, Brett Swope.
United States Patent |
8,469,977 |
Balbierz , et al. |
June 25, 2013 |
Endoscopic plication device and method
Abstract
Described herein are endoscopic plicators passed transorally
into the stomach and used to plicate stomach tissue by engaging
tissue from inside of the stomach and drawing it inwardly. In the
disclosed embodiments, the tissue is drawn inwardly into a vacuum
chamber, causing sections of serosal tissue on the exterior of the
stomach to be positioned facing one another. The disclosed
plicators allow the opposed sections of tissue to be moved into
contact with one another, and preferably deliver sutures, staples
or other means for maintaining contact between the tissue sections
at least until serosal bonds form between them. Each of these steps
may be performed wholly from the inside of the stomach and thus can
eliminate the need for any surgical or laparoscopic intervention.
After one or more plications is formed, medical devices may be
coupled to the plication(s) for retention within the stomach.
Inventors: |
Balbierz; Daniel J. (Redwood
City, CA), Cole; Dave (San Mateo, CA), Crews; Samuel
T. (Woodside, CA), Swope; Brett (Gaithersburg, MD),
Smith; Andrew (San Francisco, CA), Lunsford; John (San
Carlos, CA), Sander; Fiona (Los Altos Hills, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Balbierz; Daniel J.
Cole; Dave
Crews; Samuel T.
Swope; Brett
Smith; Andrew
Lunsford; John
Sander; Fiona |
Redwood City
San Mateo
Woodside
Gaithersburg
San Francisco
San Carlos
Los Altos Hills |
CA
CA
CA
MD
CA
CA
CA |
US
US
US
US
US
US
US |
|
|
Assignee: |
Barosense, Inc. (Redwood City,
CA)
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Family
ID: |
39015900 |
Appl.
No.: |
12/785,268 |
Filed: |
May 21, 2010 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20100228272 A1 |
Sep 9, 2010 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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11542457 |
Oct 3, 2006 |
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60825534 |
Sep 13, 2006 |
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60754417 |
Dec 28, 2005 |
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60723160 |
Oct 3, 2005 |
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Current U.S.
Class: |
606/153; 227/19;
606/139; 227/179.1; 227/176.1 |
Current CPC
Class: |
A61B
17/072 (20130101); A61F 5/0036 (20130101); A61B
17/1114 (20130101); A61B 17/115 (20130101); A61B
17/068 (20130101); A61B 17/1285 (20130101); A61B
17/1155 (20130101); A61B 2017/00827 (20130101); A61B
2017/00535 (20130101); A61B 2017/1157 (20130101); A61B
17/0218 (20130101); A61B 2017/07228 (20130101); A61B
2017/1139 (20130101); A61B 2017/07214 (20130101); A61B
17/07292 (20130101); A61B 2017/306 (20130101) |
Current International
Class: |
A61B
17/72 (20060101) |
Field of
Search: |
;227/179.1,19,176.1
;606/139,144-148,153,110,115,205,158,151 |
References Cited
[Referenced By]
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Primary Examiner: McDermott; Corrine M
Assistant Examiner: Mashack; Mark
Attorney, Agent or Firm: King & Spalding LLP Dehlinger;
Peter J.
Parent Case Text
PRIORITY
This application is a continuation of U.S. patent application Ser.
No. 11/542,457, filed on Oct. 3, 2006, now pending, which claims
the benefit of U.S. Provisional Application No. 60/723,160, filed
Oct. 3, 2005; U.S. Provisional Application No. 60/754,417, filed
Dec. 28, 2005; and U.S. Provisional Application No. 60/825,534,
filed Sep. 13, 2006, the disclosures of each are incorporated by
reference herein.
Claims
What is claimed is:
1. An apparatus for forming a stapled tissue fold composed of
opposed sections of tissue, comprising: (i) a first member having a
tissue-contact surface wherein the first member includes a staple
housing having a staple cartridge including at least one staple;
(ii) a second member having a tissue-contact surface that confronts
the tissue-contact surface of the first member; (iii) one or more
hinge members coupling the first member and the second member for
movement along an axis toward and away from one another, each of
said hinge members having proximal and distal sections that are
pivotally mounted on said first and second members, respectively,
and pivotally joined together at a central hinge, such that
movement of the two members toward one another causes the proximal
and distal sections of each hinge member to pivot outwardly away
from said axis, and (iv) a vacuum chamber defined by said hinge
members and the confronting tissue-contact surfaces of the first
and second members, and including a flexible membrane extending
between the two members, covering said hinge member(s), and
providing an opening through which tissue can be drawn into the
chamber; such that application of the vacuum to said chamber is
effective to draw a tissue fold into said chamber, through said
membrane opening, and movement of the two members toward one
another is effective (i) to enlarge the size of the chamber in the
region between the two members, increasing the size of the tissue
fold that can be drawn into the chamber upon application of a
vacuum, and (ii) ultimately to capture the tissue fold between the
confronting tissue-contact surfaces of said two members.
2. The apparatus of claim 1, wherein said membrane is formed of
silicone.
3. The apparatus of claim 1, wherein the tissue-contact surface of
the second member provides an anvil surface.
4. The apparatus of claim 1, furthering comprising a cutter carried
on the first member and extendable through tissue in the vacuum
chamber to form a hole in the tissue fold.
5. A method of forming a stapled tissue fold composed of opposed
sections of tissue with the apparatus of claim 1, comprising (i)
drawing a tissue fold into the vacuum chamber defined by the
confronting tissue-contact surfaces of the first and second members
and the hinge member(s) pivotally coupling the two members in the
apparatus, and including the flexible membrane extending between
the two members, conveying said hinge members and providing an
opening through which tissue can be drawn in to the chamber, by
applying a vacuum to said chamber; (ii) moving the first member and
the second member toward one another; (iii) by said moving,
enlarging the size of the chamber in the region between the two
members, thereby increasing the size of the tissue fold that can be
drawn into the chamber upon application of a vacuum, (iv) with
continued moving the first member and the second member toward one
another ultimately capturing the tissue fold between the
confronting tissue-contact surfaces of said two members and (v)
stapling the tissue fold.
6. The method of claim 5, further comprising: forming a hole in the
tissue fold.
7. The method of claim 6, further comprising: coupling an anchor to
the tissue fold by passing one end of the anchor through the hole
in the tissue fold.
8. The method of claim 5, for use in forming a stapled tissue
plication within a patient's stomach, further comprising:
positioning a reinforcing element against the tissue-fold surface
in contact with the tissue-contact surface of the first member
before said stapling.
9. The method of claim 5, wherein stapling the tissue fold
comprises stapling a circular array of staples in the tissue fold.
Description
FIELD OF THE INVENTION
The present invention relates generally to the field of systems and
methods for performing endoscopic surgery, and specifically to
systems and methods for endoscopic plication of tissue within body
cavities.
BACKGROUND OF THE INVENTION
An anatomical view of a human stomach S and associated features is
shown in FIG. 1A. The esophagus E delivers food from the mouth to
the proximal portion of the stomach S. The z-line or
gastro-esophageal junction Z is the irregularly-shaped border
between the thin tissue of the esophagus and the thicker tissue of
the stomach wall. The gastro-esophageal junction region G is the
region encompassing the distal portion of the esophagus E, the
z-line, and the proximal portion of the stomach S.
Stomach S includes a fundus F at its proximal end and an antrum A
at its distal end. Antrum A feeds into the pylorus P which attaches
to the duodenum D, the proximal region of the small intestine.
Within the pylorus P is a sphincter that prevents backflow of food
from the duodenum D into the stomach. The middle region of the
small intestine, positioned distally of the duodenum D, is the
jejunum J.
FIG. 1B illustrates the tissue layers forming the stomach wall. The
outermost layer is the serosal layer or "serosa" S and the
innermost layer, lining the stomach interior, is the mucosal layer
or "mucosa" MUC. The submucosa SM and the multi-layer muscularis M
lie between the mucosa and the serosa.
Several prior applications sharing inventors with the present
application, including International Application No. WO 2005/037152
having an international filing date of Oct. 8, 2004 and U.S.
application Ser. No. 11/439,461, filed May 23, 2006 (both
incorporated herein by reference) describe methods according to
which medical implants are coupled to tissue structures formed
within the stomach. According to these applications, devices for
inducing weight loss (e.g. by restricting and/or obstructing flow
of food into the stomach, and/or by occupying a portion of the
stomach volume) may be coupled to tissue tunnels or plications P
(FIG. 2) formed from stomach tissue.
For example, U.S. application Ser. No. 11/439,461 (incorporated
herein by reference in its entirety), describes a restrictive
and/or obstructive implant system for inducing weight loss. In one
embodiment, flexible loops 2 (FIG. 3) are coupled to tissue
plications P (FIG. 2) formed in the gastroesophageal junction
region of the stomach. An implant, such as a flow restrictive
and/or obstructive implant 4 (FIG. 4), is passed through the loops
2 and thus retained in the stomach as shown in FIG. 5.
In other instances, tissue plications may themselves be sufficient
to provide the necessary treatment. For example, the plications may
be used to reduce stomach volume or form a flow restriction within
the stomach.
Other types of implants may be coupled to such plications or other
tissue structures for a variety of purposes. These implants
include, but are not limited to prosthetic valves for the treatment
of gastro-esophageal reflux disease, gastric stimulators, pH
monitors and drug eluting devices that release drugs, biologics or
cells into the stomach or elsewhere in the GI tract. Such drug
eluting devices might include those which release leptin (a hormone
which creates feelings of satiety), Ghrelin (a hormone which
creates feelings of hunger), octreotide (which reduces Ghrelin
levels and thus reduces hunger), Insulin, chemotherapeutic agents,
natural biologics (e.g. growth factor, cytokines) which aid in post
surgery trauma, ulcers, lacerations etc. Still other implants might
be of a type which might provide a platform to which specific cell
types can adhere, grow and provide biologically-active gene
products to the GI tract, and/or a platform for radiation sources
that can provide a local source of radiation for therapeutic
purposes, or provide a platform whereby diagnostic ligands are
immobilized and used to sample the GI tract for evidence of
specific normal or pathological conditions, or provide an anchor
point for imaging the GI tract via cameras and other image
collecting devices.
The prior applications listed above, address the desirability of
forming tissue plications, pockets or tunnels in a way that regions
of serosal tissue (i.e. the tissue on the exterior surface of the
stomach) are retained in contact with one another. Over time,
adhesions formed between the opposed serosal layers create strong
bonds that can facilitate retention of the plication/pocket/tissue
over extended durations, despite the forces imparted on them by
stomach movement and implanted devices. More durable plications can
be created by placing any of a number of materials and/or
substances (i.e. injectable sclerosing agents) between the serosal
surfaces prior to plicating the serosal surfaces together. One
example of material suitable for this purpose is polypropolyene
mesh, commonly used for hernia repair, which when inserted in the
plication fold provides a durable anchoring position within the GI
tract.
Regardless of the application for which a plication is being
formed, it is highly desirable to form that plication using steps
carried out from within the stomach using instruments passed down
the esophagus, rather than using more invasive surgical or
laparoscopic methods. The present application describes endoscopic
plicators which may be passed transorally into the stomach and used
to form serosal-to-serosal plications in a stomach wall.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A is a schematic illustration of a human stomach and a
portion of the small intestine.
FIG. 1B is a cross-sectional perspective view of a portion of a
stomach wall, illustrating the layers of tissue forming the
wall.
FIG. 2 schematically illustrates a serosal tissue plication formed
in stomach tissue.
FIG. 3 schematically illustrates a pair of loops attached to
serosal tissue plications, prior to the positioning of a medical
implant within the loops.
FIG. 4 is a cross-sectional side elevation view of a satiation
implant.
FIG. 5 schematically illustrates the satiation implant of FIG. 4
coupled to the loops of FIG. 3.
FIG. 6 is a perspective view of an endoscopic plication system.
FIG. 7 is a perspective view of the vacuum head of the system of
FIG. 6.
FIG. 8A is a side elevation view of the cannula of the system of
FIG. 6.
FIG. 8B is a perspective view of the distal end of the cannula of
FIG. 8A.
FIG. 9 is a cross-sectional side view of an anchor of the system of
FIG. 6.
FIG. 10 is a plan view of the catch of the anchor of FIG. 9.
FIG. 11A is a plan view of the spring element of the anchor of FIG.
9.
FIG. 11B is a perspective view of the spring element of FIG. 11A,
showing the spring tabs in the opened position.
FIG. 12 is a perspective view of the vacuum head of FIG. 7, showing
the anchor of FIG. 9 positioned within the vacuum head.
FIG. 13 is a perspective view of the anchor of FIG. 9, which
includes a loop of the type shown in FIG. 3.
FIG. 14A is a perspective view of the mesh tube of the system of
FIG. 6.
FIG. 14B is cross-sectional perspective view showing the mesh tube
of FIG. 14A in the compressed orientation.
FIG. 15A is a side elevation view showing the tip, cable, mesh
tube, and sheath of FIG. 6 following assembly.
FIG. 15B is a side elevation view of the plicator of FIG. 6
assembled for use.
FIG. 16A schematically illustrates introduction of the assembled
plicator and an endoscope into the stomach.
FIG. 16B schematically illustrates creation of a tissue pocket
using the plicator of FIG. 16A.
FIG. 17A is a perspective view of a barbed stabilizing cuff.
FIG. 17B is a perspective view similar to FIG. 16B, showing use of
the barbed stabilizing cuff of FIG. 17A to stabilize tissue within
the pocket.
FIG. 18A schematically illustrates positioning of the tip element
and mesh tube following their deployment.
FIG. 18B schematically illustrates the stomach exterior surface
following deployment of the tip and anchor.
FIG. 19A illustrates compression of the anchor using the plicator
and cable.
FIG. 19B shows the final anchor and mesh position following removal
of the plicator and endoscope.
FIG. 20 illustrates an alternative method for compressing the
anchor.
FIGS. 21A through 21C are perspective views illustrating an
alternative vacuum chamber in which the vacuum chamber also forms
the implantable anchor.
FIGS. 22A through 22D are a sequence of steps illustrating an
alternative method using a vacuum paddle that additionally
functions as an implantable anchor.
FIGS. 23A through 23B and 24A through 24B are a sequence of steps
illustrating an alternative method which forms a serosal tunnel and
positions a leg of an anchor within the serosal tunnel. FIGS. 23A
and 23B are cross-sectional side views. FIGS. 24A and 24B are
perspective views taken from within the stomach.
FIG. 25A is a perspective view taken from within the stomach
illustrating the serosal tunnel formed during the sequence of steps
illustrated in FIGS. 23A through 24B.
FIG. 25B is a cross-section view of the serosal tunnel and anchor
shown in FIG. 25A.
FIG. 25C illustrates placement of two of the anchors of FIGS.
23A-24B within a stomach.
FIGS. 26A through 26C are cross-sectional side views of a plication
system and a stomach wall, illustrating an alternative method in
which a sclerosing agent is injected into the serosal pocket prior
to advancement of the tip element.
FIGS. 27A and 27B are cross-section views illustrating a method for
sealing sclerosing agent within the serosal pocket using a
clamp.
FIGS. 28 and 29, in which FIG. 28 is a perspective view and FIG. 29
is a cross-section view of a distal end of a plication system and a
portion of the stomach wall, illustrate methods for sealing
sclerosing agent within the serosal pocket using the vacuum
head.
FIGS. 30A through 30D are a sequence of side views of a stomach
wall engaged by a vacuum chamber, and illustrate steps of an
alternative method of forming a tissue plication using sclerosing
agents.
FIGS. 31A and 31B illustrate alternate place holding elements for
use in the method of FIGS. 30A-30D.
FIGS. 32A and 32B illustrate the use of clamps to retain plications
formed using the FIG. 30A-30D method during healing of the
plications.
FIG. 33A is a perspective view of a serosal plication having a
cutout formed through the tissue. FIG. 33B is a cross-section view
of a stomach illustrating three serosal plications of the type
shown in FIG. 33A.
FIG. 34A is a cross-sectional side view of a second preferred
embodiment of a plication system.
FIGS. 34B-34G are a sequence of cross-sectional side views
illustrating formation of a plication of the type shown in FIG. 33A
using the system of FIG. 34A.
FIG. 35A is a cross-section side view of the plication formed in
accordance with the method of FIGS. 34A-34G.
FIG. 35B is a cross-sectional plan view taken along the plane
designated 35B-35B in FIG. 35A.
FIG. 36A is a perspective view of the plication head of an
alternative embodiment of a plicator, shown in the streamlined
positioned for transoral delivery to the stomach. The shroud is not
shown to allow clear viewing of the underlying components.
FIG. 36B is a perspective view similar to FIG. 36A showing the
plication head in the expanded position. The shroud is not shown to
allow clear viewing of the underlying components.
FIGS. 37A through 37D are a sequence of cross-sectional perspective
views of the plication head of FIGS. 36A and 36B, illustrating a
method of using the plication head. The shroud is not shown to
allow clear viewing of the underlying components.
FIG. 38 is a bottom plan view of the plication head of FIGS.
36A-37C with the shroud in place and the hinge members in the
expanded position.
FIG. 39 is a front elevation view of the plication head as
positioned in FIG. 38.
FIG. 40A is a cross-sectional side views of the hydraulic chamber a
piston assembly used for expanding the vacuum chamber, compressing
tissue, and driving the staples in the embodiment of FIGS.
36A-39.
FIG. 40B is a cross-sectional side view of the staple driver of the
embodiment of FIGS. 36A-37D.
FIGS. 41A and 41B are side elevation views of a modified plication
head with the shroud not shown to permit the underlying components
to be seen.
FIG. 41C is a perspective view of the plication head of FIGS. 41A
and 41B, with the shroud shown.
FIG. 42A is a perspective view of an expandable frame for deploying
a reinforcing element. FIG. 42B shows a reinforcing element on the
frame of FIG. 42A.
FIGS. 43A and 43B are plan views illustrating staple patterns.
FIGS. 43C-43E are plan views illustrating interlocking staple
patterns.
FIGS. 44A and 44B are plan views of reinforcing rings.
FIG. 45A is a perspective view showing the reinforcing ring of FIG.
44B on a stapler anvil.
FIG. 45B is a plan view of the reinforcing ring of FIG. 44A on a
staple cartridge.
FIGS. 46A and 46B are plan views of a tissue plication, in which
FIG. 46A shows the side of the plication positioned on the staple
cartridge side of the plicator, and FIG. 46B shows the side of the
plication position on the anvil side of the plicator.
FIG. 47A is a cross-sectional top view of a stomach, illustrating
movement of cutout plications into alignment in preparation for
insertion of an implant through their cutouts.
FIG. 47B is a cross-sectional side view of a stomach, illustrating
the alignment step of FIG. 47A.
FIG. 47C is a cross-sectional side view similar to FIG. 47B, with
the implant in place within the cutouts.
FIG. 48A is a cross-sectional top view of a stomach illustrating an
arrangement of cutout plications.
FIG. 48B is a cross-sectional top view similar to FIG. 48A, showing
the cutout plications drawn into alignment with one another.
FIG. 48C is a cross-sectional top view similar to FIG. 48B, showing
an implant positioned in the aligned cutouts of the plications.
FIG. 48D is a cross-sectional side view of the stomach,
illustrating the formation of a food passage in the stomach using
the arrangement of plications and the implant shown in FIG.
48C.
FIG. 49 is a perspective view of a restrictive implant having
buttons insertable through holes formed in stomach tissue
plications.
DETAILED DESCRIPTION
The present application describes endoscopic plicators which may be
passed transorally into the stomach and used to plicate stomach
tissue by engaging tissue from inside of the stomach and drawing it
inwardly. In the disclosed embodiments, the tissue is drawn
inwardly into a vacuum chamber, although tissue may be drawn
inwardly using other components that do not involve the use of a
vacuum. When a portion the stomach wall is drawn inwardly, sections
of serosal tissue on the exterior of the stomach are positioned
facing one another. The disclosed plicators allow the opposed
sections of tissue to be moved into contact with one another, and
preferably deliver sutures, staples or other means for maintaining
contact between the tissue sections at least until serosal bonds
form between them. Each of these steps may be performed wholly from
the inside of the stomach and thus can eliminate the need for any
surgical or laparoscopic intervention. After one or more plications
is formed, medical devices (including, but not limited to any of
the types listed above) may be coupled to the plication(s) for
retention within the stomach.
Certain of the disclosed plicators pass a mesh element and/or a
quantity of sclerosing agent through the stomach wall such that it
is disposed between the opposed regions of serosal tissue thus
enhancing serosal bonding. Some embodiments include a feature that
forms a hole in a plication using the plication device, so that a
portion of a medical implant may be passed through or linked to the
hole the plications. Others of the embodiments are configured to
couple an anchor to the plication as it is formed, so that a
medical implant may later be coupled to the anchor.
While this application describes plication systems and methods with
respect to the formation of plications in stomach tissue, the
embodiments described herein have equal applicability for forming
plications in parts of the body outside the GI system.
Plication System of the First Preferred Embodiment
FIG. 6 illustrates one embodiment of a system 10 for tissue
plication that is suitable for endoscopic use, as well as surgical
or laparoscopic use if desired.
Generally speaking, system 10 includes a plicator 12 having a
vacuum head 14 and a shaft 16. The system further includes a
flexible anchor 18 for attachment to stomach tissue, a tissue
penetrating tip element 20 having a cable 22, a mesh element 24,
and a sheath 26.
Referring to FIG. 7, vacuum head 14 defines a vacuum chamber 28
having an opening that, during use, is positioned into contact with
stomach tissue so as to draw the tissue into the chamber 28. Vacuum
head 14 further includes slots 32, 34 sized to receive portions of
the anchor 18 as described below. The distal and proximal ends of
the vacuum head 14 include U-shaped openings 36, 38.
Referring once again to FIG. 6, shaft 16 is a flexible elongate
member extending from the proximal end of the vacuum head 14. Shaft
16 is equipped with pull-wires (not shown) and/or alternative means
for articulating the vacuum head 14 as needed for proper
positioning within the stomach. Shaft 16 includes a distal portion
40 having a generally U-shaped slot 42 corresponding to the
U-shaped opening 38 in the vacuum head. The proximal portion 46 of
shaft 16 is tubular and includes at least one lumen 48 extending
its length.
A tubular cannula 50 extends through the shaft 16 as shown in FIG.
6. Cannula 50 is fluidly coupled to a source of negative pressure
such as a syringe or vacuum pump. Application of suction to the
cannula 50 creates a vacuum in the vacuum chamber as discussed in
detail below. As most clearly visible in FIGS. 8A and 8B, cannula
50 includes an annular flange 53 (FIGS. 8A and 8B) surrounding its
distal end. A plurality of proximally-oriented ratcheting elements
51 (FIG. 8B) are positioned within the lumen of cannula 50,
adjacent to the cannula's distal end.
Anchor 18 includes a distal tab 52 and a proximal tab 54 on
opposite ends of a central portion 56. Anchor 18 is a flexible
element formed of silicone or other flexible, biocompatible
material. Its properties permit it to be deformed into the
orientation shown in FIG. 9 for insertion into the vacuum head.
More specifically, the anchor 18 is positionable within the vacuum
head 14 as shown in FIG. 12 with the distal tab 52 disposed in
distal slot 32 and the proximal tab 54 within proximal slot 34.
As best seen in the cross-section view of FIG. 9, a catch 58 is
seated within a recess in the distal tab 52 of anchor 18. Catch 58
may be formed of a resilient material such as stainless steel,
nitinol, or resilient polymer that has been over-molded using
rubber. As will described in detail below, catch 58 functions to
engage a portion of the tip element 20 (FIG. 6) after it has been
advanced through the tissue undergoing plication. In the
illustrated embodiment, catch 58 includes a cutout 60 proportioned
to engage the tip 20, however any alternative configuration for the
cutout 60 and tip 20 that will permit engagement of the two is
equally suitable. A rubber protrusion 62 is positioned on the
anchor 14 to receive the sharp tip of the tip element to prevent
injury to surrounding tissue.
Referring again to FIG. 9, proximal tab 54 includes an opening 64
within which a spring element 66 is positioned. Materials used for
the spring element may be similar to those used for the catch 58.
Spring element functions to engage cable 22 to retain the anchor in
position, and it should be appreciated that alternative features
that can perform this function can instead be used. As best shown
in FIG. 11A, a preferred spring element 66 includes a pair of tabs
68 that can be pushed to a slightly outward orientation (see FIG.
11B) when acted upon by a force shown by arrow A in FIG. 9, but
that will return to the closed orientation when the force is
relieved. Tabs 60, in their closed orientation, define a central
cutout 70.
It is appropriate to note that anchor 18 may take many alternate
forms without departing from the scope of the invention. For
example, in one alternative embodiment shown in FIG. 13, anchor 18a
includes a loop 2 of the type described in connection with FIGS.
2-5 coupled to its distal end.
Referring again to FIG. 6, tip element 20 includes a piercing
element that is sufficiently sharp to penetrate abdominal wall
tissue when subjected to an appropriate amount of force. The tip
element 20 may be formed of stainless steel or any other material
suitable for this purpose. A preferred tip element includes a
collar 73 which defines a recess 72 between the distal edge of the
collar and the proximal edge of the tip. Recess 72 is proportioned
to seat within the cutout 60 (FIG. 10) of the anchor's distal catch
58 when the tip element is passed through the cutout 60.
Cable 22 is coupled to the proximal portion of the tip element 20.
Cable 22 preferably includes a series of barbs 74, teeth, or other
engagement elements. As will be described in connection with FIG.
19A, during use the cable is engaged by spring element 66 which
allows the cable to slide in a proximal direction but that prevents
movement of the cable in a distal direction. In other words, the
cable functions in a manner similar to a cable tie found in
hardware stores.
As discussed, the system is preferably designed to pass material
between the serosal tissue layers so as to faciliate serosal tissue
bonding. The material may be a synthetic or non-synthetic mesh
(formed of nitinol or other material), porous or non-porous
material, slotted material, or any other material through which
adhesions will form or onto which tissue will grow. Examples
include, but are not limited to, polypropylene, materials sold
under the trade names Goretex or Dacron, or tissue graft material
such as the Surgisis material sold by Wilson Cook Medical, Inc. The
material may be treated with tissue-ingrowth promoting substances
such as biologics.
The delivered material can be constructed into any shape or
configuration that will achieve its purpose of promoting strong
serosal adhesions. As illustrated in FIGS. 14A and 14B, a
convenient form for the delivered material is that of a mesh tube
24 designed such that application of compressive forces between the
proximal and distal ends will cause the mesh to take the form of a
disk, or such that it will self-expand to a disk-like shape when
released from a restrained position. Tubular caps 76a, 76b formed
of a suitable polymeric material may be attached to the distal and
proximal ends of the tube to minimize damage to the mesh during
compression.
Exemplary Method of Using the First Preferred Embodiment
One method of using the system of FIG. 6 will next be
described.
In preparation for use, tip 20, cable 22, mesh element 24, and
sheath 26 are assembled for insertion into cannula 50.
Specifically, as shown in FIG. 15A, mesh tube 24 is threaded over
cable 22 and positioned such that its distal cap 76b abuts the
collar 73 of tip 20. Sheath 26 is positioned over the mesh tube 24
and advanced such that its distal end is also in contact with the
collar 73.
Referring to FIG. 15B, the assembled tip, cable, mesh element and
sheath are inserted into the cannula 50. Anchor 18 is seated within
the vacuum chamber 28 as described above. The flange 53 of the
cannula 50 is positioned in sealing contact with the anchor 18. For
example, the flange 53 may be inserted into the proximal opening 64
(FIG. 9) of the anchor so as to create an interference fit between
the two. Adequate sealing is desirable to prevent loss of vacuum
pressure from the vacuum chamber 28 during use.
Next, the assembled plicator 12 is passed into the stomach S via
the esophagus as shown in FIG. 16A. An endoscope 80 is also passed
into the stomach to provide visualization of the procedure.
Although the endoscope 80 is shown as a separate component, the
plicator 12 may be modified to include an integrated endoscope.
Referring to FIG. 16B, the plicator 12 is advanced to a target
location at which a plication is to be formed. The plicator is
manipulated using pull wires or other steering elements to place
vacuum chamber 28 against the stomach tissue. Suction is applied to
the vacuum chamber 28 via cannula 50, thus drawing stomach tissue
into the vacuum chamber as shown. Consequently, a pocket 100 forms
in the tissue such that if the stomach were to be viewed from the
outside a depression in the stomach wall would be visible. Suction
is maintained to stabilize the tissue within the vacuum chamber. If
additional stabilization of the tissue is desired, the plicator 12
may be provided with a barbed stabilization cuff 82 of the type
shown in FIG. 17A. Cuff 82 includes a plurality of barbs 84
oriented to penetrate stomach tissue as shown in FIG. 17B when the
tissue is drawn into the chamber 28, thus holding the proximal
portion of the captured tissue in place during advancement of the
tip member 20 and mesh 24 element. Other stabilizing mechanisms may
alternatively be used in lieu of, or in addition to, the cuff and
barbs.
At this point, the tissue is ready for advancement of the tip
member 20 through the tissue, as well as deployment of the mesh
tube 24 into the pocket 100. Advancement of the tip and deployment
of the mesh may be performed in a single step, or they may be
formed as a sequence of steps. For simultaneous advancement and
deployment, sheath 26 is advanced in a distal direction, thereby
driving the tip 20 distally through the tissue walls 102 defining
the pocket 100. If the forces of friction between the tubular mesh
element 24 and the sheath 26 are sufficiently large, the advancing
sheath carries the mesh tube 24 into the pocket. Alternatively, a
pushing mandrel 86 (shown in FIG. 17B) may be advanced distally
against the proximal cap 76a of the mesh element 24 to advance the
mesh element 24 into the pocket 100. If separate advancement of the
tip member 20 and deployment of the mesh element 24 is preferred,
the tip member 20 is first driven in a distal direction by distal
movement of the sheath 26, and the mesh element is then separately
pushed over the cable 22 using the mandrel 86.
Many alternative structures useful for separately or simultaneously
applying pushing forces to the tip element 20 and the mesh element
24 are readily conceivable and may also be used.
Regardless of the mode of deployment, as the tip member 20 is
advanced, its pointed distal end moves into contact with the spring
element 66 on the anchor 18, causing tabs 68 (FIGS. 9, 11A and 11B)
to push distally into the position shown in FIG. 11B, and to then
return to their substantially planar orientation (FIG. 11B) once
the tip member 20 has cleared the spring element 66. The tip
element 20 then passes through the walls 102 of tissue and into
engagement with the distal catch 58 of the anchor 18 (i.e. the
edges of the cutout 60 seat within recess 72 of the tip element
20), thereby locking the tip element to the catch 58. The
distal-most portion of the tip element 20 embeds within the
protrusion 62 of the anchor.
The cable 22 remains attached to the tip element 20 and thus
extends through the walls 102, through catch 58 and spring element
66, and through the cannula 50. The mesh tube 24 remains disposed
around the cable 22. FIG. 18A is a cross-section view of the
stomach illustrating the arrangement of the components after the
tip element 20 and mesh tube 24 have been deployed. FIG. 18B shows
the outside of the stomach at this stage of the procedure.
The next series of steps are geared towards drawing the distal and
proximal tabs 52, 54 of the anchor 18 towards one another, so as to
enclose the mesh element 24 within the pocket 100. Referring to
FIG. 19A, the vacuum head 14 is moved in a lateral direction until
it separates from the anchor 18 and the pocket 100. (If a barbed
stabilization cuff 82 of the type shown in FIG. 17A has been used
to engage the tissue, the cuff is first rotated to "unscrew" its
barbs from the tissue. This might be achieved, for example, using a
rotatable element (not show) that may be grasped and rotated by the
user.) Vacuum head 14 is then positioned against the anchor 18 and
used to impart a distally-oriented force against the proximal side
of the anchor 18. At the same time, fraction is applied to cable 22
so as to impart proximally directed forces to the distal end of the
anchor. Ratcheting elements 51 in the cannula 50 prevent the cable
22 from sliding distally in the event that traction of the cable 22
is momentarily released.
The opposed forces between cable 22 and vacuum head 14 result in
compression of the anchor 18 and the mesh tube 24 into the
illustrated positions. As the cable 22 tightened, the spring
element 66 of the anchor sequentially engages barbs on the cable
22. Once tension on cable 22 is released, the spring element 66
remains engaged with the adjacent barb on the cable so as to retain
the anchor in the compressed position. Finally, the cable 22 is
clipped, and the plicator 12 is withdrawn from the body, leaving
the anchor 18 and mesh positioned as shown in FIG. 19B. The
procedure may be repeated to form multiple plications if needed.
Following formation of the plication(s), a medical implant may be
coupled to the anchor(s) 18 during the course of the same procedure
or during a later procedure scheduled to permit sufficient
formation of adhesions between the serosal tissue layers 102 to
support the implant.
It should be noted with reference to FIG. 20 that in an alternative
method, the cannula 50 may remain coupled to the anchor 18 during
lateral movement of the vacuum head 14, causing the proximal
portion 40 of the shaft 16 to separate from the cannula 50.
According to this embodiment, the anchor 18 may be compressed by
pressing the cannula 50 downwardly against the anchor 18 while
applying tension to the cable 22. Once the anchor has been secured
as described with respect to FIGS. 19A and 19B, the cannula 50 is
detached from the anchor 18 and withdrawn from the body.
Alternatives to the First Embodiments
One alternative system illustrated in FIGS. 21A through 21C is
similar to the first preferred embodiment, but differs in that the
vacuum head 14e is formed of a compliant material such as silicone
and also functions as the anchoring device. During use of the
vacuum head 14e, suction is applied to draw tissue into the vacuum
head, and a cable 22e (or suture, etc) is passed through the
compliant silicone material to form the tissue plication. If
necessary, a removable rigid housing 98 may be positioned around
the vacuum head to prevent it from collapsing during application of
suction.
In another alternative system shown in FIGS. 22A through 22D, a
flexible vacuum paddle 110 is positionable into contact with
stomach tissue. In this embodiment, paddle 110 also serves as the
anchor that will remain coupled to the tissue.
Paddle 110 includes an elongate tube 112 that extends through the
esophagus and is connectable to a vacuum source 114 positioned
outside the body. Paddle 110 is formed of silicone or other
flexible material suitable for long term implantation. Loop 2 is
integrally coupled to the paddle. An elongate spine 116 is
positionable against the paddle 110, and may include elements for
temporarily engaging the paddle 110. Spine 116 includes pull wires
or other features that may be manipulated from outside the body to
deflect it and the adjacent paddle 110 into nested curved positions
as shown in FIG. 22B, thus creating a pocket 100 in the tissue. A
tip 120 coupled to a cable 122 may be advanced through the elongate
tube 112 such that it penetrates the tissue lining the pocket 100
and advances into a portion of the paddle 110, where it is engaged
by a catch (e.g. see catch 58 of FIG. 8A). A mesh element 124 may
be advanced over the cable 122 as shown in FIG. 22C, and the cable
122 may be cinched to form the plication using techniques such as
those described above, leaving the paddle 110 and loop 2 in
place.
An alternative system illustrated in FIGS. 23A and 23B is similar
to the system of the first embodiment of FIG. 6. Specifically,
system 10f includes a vacuum head 14f mounted at the distal end of
a shaft 16f of sufficient length to permit the vacuum head 14f to
be positioned within the stomach while the proximal portion of the
shaft 16f remains outside the oral cavity. The vacuum head is
coupled to a source of suction, such as a syringe or vacuum
pump.
A flexible anchor 18f is seated within vacuum head 14f prior to
use, similar to the positioning of the anchor 18 of the first
embodiment shown in FIG. 12. The anchor 18f includes a distal tab
52f and a proximal tab 54f having corresponding openings
longitudinally aligned with the lumen 48f of the shaft 16f. The
system differs from the first embodiment in that the anchor 18f
further includes an elongate leg 22f that is coupled to the tabs
52f, 54f during assembly to form the anchor 18f into a loop. Leg
22f includes a tip 20f and a catch 21f positioned to engage the
distal tab 52f and the proximal tab 54, respectively. The leg 22f
may be manufactured of a flexible polymeric material such as
silicon, or it could be formed of a mesh, braid, stent into which
surrounding tissue will grow. However, the tip 20f should be
capable of penetrating stomach wall tissue.
Prior to use, the leg 22f is positioned within the lumen 48f of
shaft 16f. During implantation of the anchor 18f, serosal tissue is
drawn into the vacuum head 14f as shown in FIG. 23A. The leg 22f is
advanced through the tabs 52f, 54f, and the sections of stomach
wall lying between the tabs, using a push rod (not shown) or other
pushing mechanism as described above. The tip 20f engages with
distal tab 52f and the catch 21a is restrained by proximal tab 54f.
The vacuum head 14f is subsequently removed, leaving the anchor and
leg forming a loop surrounding a portion of the stomach wall as
shown in FIG. 23B.
Although the method of implanting the anchor 18f may end with the
anchor 18f positioned as shown in FIG. 23B, it is preferable to
bring some of the serosal tissue surfaces surrounding pocket 100
into contact with one another so as to trigger growth of serosal
bonds between the contacting tissues surfaces, as described before.
Methods for cinching the tissue to form a serosal plication are
described above and may be modified for use with the FIGS. 23A-23B
method. Alternatively, elongate regions of tissue on opposite sides
of the leg 22f may be brought into contact with one another and
clamped, stapled and or otherwise held in contact to turn the
pocket 100 into a sealed serosal pocket 100f surrounding the leg
22f and isolated from the sterile environment outside the stomach.
For example, as shown in FIG. 24A, a jaw-type stapling instrument
92 having a vacuum housing 93 may be endoscopically introduced into
the stomach and positioned with the jaws 94a, 94b contacting
mucosal tissue on opposite sides of the leg 22f. This instrument
may be separate from the instrument used to couple the anchor 18f
to the tissue, or the instrument of FIG. 23A may be modified to
include the stapler jaws 94a, 94b.
The jaws are clamped as shown in FIG. 24B to bring the serosal
tissue surfaces together, and staples are passed through the tissue
using the jaws, enclosing the pocket 100 in the tissue and helping
to retain the anchor using the re-shaped stomach tissue. After the
instrument 92 is removed from the stomach, the serosal tissue
surfaces remain held in contact by one or more staple lines 95
(FIGS. 25A and 25B). The staple lines 95 seal the pocket 100f and
reduce the chance of infection by forming a barrier preventing
gastric contents that might enter the pocket 100f from moving into
the extra-gastric space. Adhesions will then form between the
serosal tissue surfaces as described above. To optimize the
strength of the adhesions, the leg 22f may include
ingrowth-promoting features. For example, leg 22f may be configured
to support macro-level ingrowth using a mesh design, or it may
include micro-ingrowth promoting features such as a porous surface.
Leg 22f might alternatively or additional have a surface coated or
impregnated with sclerosing agents. Multiple anchors 18f may be
implanted using this method, as shown in FIG. 25C.
In alternate plication methods, one or more sclerosing agents may
be used in conjunction with or in lieu of the mesh element 24.
Examples of sclerosing agents include but are not limited to Sodium
Tetradecyl Sulfate (STS), Poliodocanol, Chromated Glycerin,
Hypertonic saline, Sodium Morrhuate, Sclerodex (hypertonic saline
in combination with Dextrose). Other substances that may be
positioned with or in place of the mesh element 24 include
methylmethacrylate, glues, adhesives, and biorubbers. These may be
injected at the time of mesh placement or loaded into the mesh
itself and eluded out over a period of time.
FIGS. 26A through 26F illustrates an alternative method in which a
cannula 50a having a tissue-penetrating distal end is passed into
the tissue pocket 100 for delivery of an agent. According to the
alternative method, tissue pocket 100 is formed using methods
similar to those described above. Cannula 50a is advanced through
the shaft 16a of the plicator 12a, through anchor 18a and tissue
102, and into the pocket 100. The desired agent is passed through
the cannula 50a and into the pocket.
Once the agent is administered, steps similar to those described
above may be performed to form the plication and to attach anchor
18a to the plication. Tip 20a (FIG. 26B) is thus advanced through
the cannula 50a (or through a separate cannula introduced upon
removal of the cannula) and advanced as described in connection
with the first embodiment. If a mesh element 24a is to be
introduced, it may be positioned around the cable 22a as described
previously. A pusher tube 86a may be threaded over the cable 22a,
through the interior of the mesh tube 24a, and into contact with
proximal cap 76a on the mesh element 86a. Sliding the pusher tube
86a distally drives the tip 20a through the plication and into
engagement with a distal catch 58a on the anchor, as also advances
the mesh element 24a into the pocket 100. In a final sequence of
steps, the plication may be "cinched" using methods similar to
those described above.
In certain instances, it might be desirable to completely close the
serosal pocket 100 to avoid leakage of injected agents into the
peritoneal cavity. The pocket 100 may be sealed using an elongate
clamp 90 endoscopically introduced into the stomach and clamped
over the tissue pocket to press the serosal surfaces into contact
with one another as shown in FIGS. 27A and 27B. Alternatively,
vacuum head 14c (FIG. 28) may include clamping bars 92, such as
elongate rods or inflatable balloons, that are positioned on
opposite sides of the pocket to clamp the pocket 100 between them.
As yet another alternative, the vacuum head 14d may be biased or
hinged to clamp the pocket 100 as shown in FIG. 29.
An alternative method for forming plications using sclerosing
agents to accelerate scar formation is illustrated in FIGS. 30A
through 30E. This method is advantageous in that it allows
plications to be formed without the use of sutures or cables, and
thus can simplify the procedure.
As with previous methods, a pocket 100 or depression is formed on
the serosal surface by drawing a portion of the stomach wall
inwardly using a vacuum head 14f or other device introduced
transorally into the stomach. A delivery member 130 is next
introduced into the stomach. The delivery member 130 is an elongate
tubular device having a lumen through which a sclerosing agent may
be delivered, as well as a delivery means for delivering a place
holding element 132 into the pocket 100. The delivery member 130
preferably includes a sharpened distal tip capable of penetrating
the stomach wall.
As shown in FIG. 30B, the delivery member 130 is advanced through
at least one portion of the stomach wall 102, and used to deliver
the place holding element 132 into the pocket 100. The place
holding element 102 functions to maintain separation between
opposed serosal walls 102, so that the volume between the walls can
be filled by a sclerosing agent introduced by the delivery member
130 or a separate delivery method.
In one embodiment, the place holding element 132 may be delivered
by pushing it through the lumen of the delivery member using a
pushing mandrel. The place holding element might be a section of
material that has a compact size and shape for delivery by the
delivery member 130, but that expands upon delivery into the pocket
100. To give a few examples, the element may be formed of a
structure having mechanical properties (e.g. sponge or nitinol
mesh) that cause it to self-expand when released from the delivery
member, or it may be an inflatable balloon tethered to an inflation
lumen in the delivery member, or it may be a swellable hydrogel
that will increase in volume once exposed to fluid within the
pocket (e.g. the sclerosing agent or other fluid injected into the
body, and/or fluids present in the peritoneal cavity). In alternate
embodiments the place holding element might be delivered directly
to the outside of the stomach using laparoscopic methods.
The element may be formed of a permanent or semi-permanent material
(such as the examples described in connection with mesh element 24
above), that will reinforce the plication and/or work together with
the sclerosing agent to promote scar formation. Alternatively, the
element may be one that is biodegradable or bioabsorbable over a
period of time.
Once the place holding element 132 has been positioned, the vacuum
head 14f or a separate clamping device is utilized to clamp and
seal the pocket 100 as shown in FIG. 30C (see, for example, the
sealing methods described above). Sclerosing agent is injected
through the delivery member 130 into the pocket 100. Referring to
FIG. 31A, if the place holding element is an inflatable balloon
132a or another type of element that can seal against the tissue
forming the pocket, it may be acceptable to eliminate the step of
applying sealing forces to the pocket. Referring to FIG. 31B, use
of a sponge 132b in lieu of balloon 132a may minimize migration of
sclerosing agent out of the cavity. The sponge 132b may be filled
with sclerosing agent prior to its delivery into the pocket 100, or
it may instead absorb agent introduced into the pocket.
Sealing forces continue to be applied to the pocket 100 until ample
scar tissue has formed within the pocket to maintain the P. Once
adequate scar tissue has been formed, sealing forces may be
released and the vacuum head removed from the stomach. If the
balloon of FIG. 31A is used in lieu of sealing forces, inflation of
the balloon is maintained until the sclerosing agent has formed an
adequate amount of scar tissue.
It should be noted with reference to FIGS. 32A and 32B that if
sealing forces are needed over an extended during (i.e. to ensure
sufficient tissue scarring to retain the plication), a clip 134a
may be clipped around the plication to maintain the plication until
sufficient scarring has occurred. If needed to prevent unwanted
detachment of the clip, an alternative clip 134b (FIG. 31B) may
include prongs positioned to pass through the tissue.
Plication System of the Second Preferred Embodiment
In many instances it may be desirable to form serosal tissue
plications of the type shown in FIG. 33A, which include a cutout C
or hole formed through the plication P. As shown in FIG. 33B,
multiple such plications may be formed within the stomach to
provide a platform for mounting an intragastric device or for other
purposes that will be described below.
When a cutout plication is formed, it may be beneficial to form a
seal around the cutout C using staples, sutures or adhesives etc so
as to prevent food material and/or gastric juices from passing
between the opposed layers of serosal tissue where they can
potentially cause infection between the tissue layers or within the
extra gastric space. In the FIG. 33A example, a circular array of
staples is placed in the tissue surrounding the cutout C for this
purpose. Sealing the cutout using staples provides the additional
benefit of controlling the bleeding that will occur along the edges
of the cutout. In forming the plication P, reinforcing mesh or
other suitable material may be positioned between the opposed
serosal layers so as to achieve the benefits discussed in
connection with the first embodiment.
A second preferred embodiment of a plication system 10g, shown in
cross-section FIG. 34A, is particularly useful for forming a
serosal plication having a cutout surrounded by a staple line, and
also for positioning a reinforcing mesh element within the
plication.
In general, system 10g includes a plicator 12g comprising a vacuum
head 14g having a vacuum chamber 28g and a shaft 16g defining a
lumen 48g. A port 49 is fluidly coupled to the vacuum chamber 28g
and is connectable to an extracorporeal source of suction (e.g. a
syringe or a vacuum pump).
An elongate staple driver 150 is longitudinally moveable within the
lumen 48g. Staple driver may take the form of an elongate tube
having a broadened annular head 152 positioned within the vacuum
head 14g. A plurality of staples 154 is arranged adjacent to the
staple head, preferably in a circular arrangement, but alternative
arrangements are equally suitable. A circular anvil 156 is
positioned within the vacuum head 14g opposite the staples. Staple
driver head 152 is moveable in a distal direction to advance the
staples across the vacuum chamber and into contact with the anvil
156.
The system includes a tubular cannula 50g for forming the cutout C
in the tissue. Cannula 50g extends through the lumen of the staple
driver 150, with its tissue-penetrating distal end oriented towards
the vacuum chamber 28g. Cannula 50g may be advanced in a distal
direction to extend through the vacuum chamber 28g and into a
tubular channel 158 formed in the distalmost section of the vacuum
head.
An elongate rod 160 having a pointed distal barb or tip 20g extends
through the lumen of the cannula 50g. Tubular mesh element 24g
surrounds a portion of the exterior surface of rod 160, with its
distal end adjacent to the proximal end of tip 20g. Mesh element
24g is preferably a self-expandable tubular element of the type
described in connection with FIGS. 14A and 14B. When positioned on
the rod 160, the mesh element is compressed to a reduced-diameter
position and retained in the compressed position using a retention
sleeve 162. A tubular support 164 may be positioned on the rod 160
in abutment with the proximal end of the mesh element 24g.
System 10g further includes a proximal handle (not shown) that
remains outside the body during use of the system. The handle
includes actuators, pull wires, push rods, or equivalent components
that facilitate longitudinal advancement and withdrawal of the tip
20g, cannula 50g, retention sleeve 162, and staple driver 150, as
well as deflection or articulation of the components, as needed to
carry out the method for using the system described in the
following section.
Exemplary Method for Using the Second Preferred Embodiment
A method for using the system of the second embodiment will next be
described. First, the vacuum head 14g is introduced into a stomach
and endoscopically positioned with the vacuum chamber facing the
interior surface of the stomach wall. This step is similar to the
step illustrated in FIGS. 16A-16B in connection with the first
embodiment.
Suction is applied to the vacuum head 14g via port 49 to draw a
portion of the stomach wall into the chamber as shown in FIG. 34B,
thus orienting sections S1, S2 of the stomach wall with their
serosal surfaces generally facing one another.
Next, the rod 160 is advanced to drive tip 20g through the sections
S1, S2. Tip 20g is captured within the channel 158 adjacent to
anvil 156. The mesh element 24g is carried by the rod 160 into
position between the stomach wall sections S1, S2. The retention
sleeve 162 is retracted, allowing the mesh element 24g to expand to
the position shown in FIG. 34D. One or more centering struts 166
extend between the mesh element 24g and rod 160 and maintain the
mesh element in a generally centered orientation relative to the
rod 160.
After the mesh element 24g is deployed, the tissue is compressed to
the position shown in FIG. 34E to bring the opposed sections S1, S2
of the stomach wall into contact or close proximity with one
another and to compress the mesh element 24g into a disk shape
(also see FIG. 14B). This folding/compressing step may be
accomplished by folding the vacuum chamber 14g itself, such as by
pushing the shaft 16g in a distal direction while maintaining
traction on the rod 160. After folding, the staple driver head 152
is pushed distally, driving the staples 154 through the tissue and
against the anvil 156 as shown in FIG. 34F. In a simultaneous or
separate step illustrated in FIG. 34G, the cannula 50g is advanced
to core the tissue, thus forming the cutout C and snipping the
centering struts 166 (not visible in FIG. 34G) connecting the mesh
element to the rod 160. In forming the cutout C, the cannula 50g
removes a margin of tissue surrounding the punctures created by tip
20g during its advancement towards channel 158.
The cannula 50g and tip 20g are withdrawn into shaft 16f, and the
vacuum head 14g is separated from the tissue, leaving the cutout
reinforced plication as shown in FIGS. 35A and 35B.
Plication System of the Third Preferred Embodiment
A third embodiment of a plicator 200 is shown in FIGS. 36A through
39. Plicator 200 includes a plication head 202 positioned on the
distal end of an elongate shaft 204. As with prior embodiments,
shaft 204 is of sufficient length to allow passage of the plication
head 202 through the mouth and esophagus into the stomach, while
the proximal end of the shaft remains outside the body. A vacuum
source 206 is fluidly coupled to the proximal end of the shaft 202.
Pullwires 208 extend through the shaft 204 from a handle (not
shown) in the proximal end of the shaft and are anchored to a more
distal location within the shaft 204, so that manipulation of the
pullwires by a user allows for steering/deflection of the plication
head 202. Shaft 204 may be formed of a plurality of spine members
that articulate relative to one another but that may be locked in a
desired position to fix the spine a desired shape.
Plication head 202 includes a tapered, atraumatic, distal tip 210
and a proximal portion 212 coupled to one another by one, two or
more hinge member 214. In the FIGS. 36A-39 embodiment, three hinge
members 214 are shown. Each of the illustrated hinge members
includes distal and proximal hinge plates 216a, 216b joined
together at central hinge 218. The hinge members 214 are moveable
between the generally elongated position shown in FIG. 36A, and to
the expanded position of FIG. 36B in which the central hinge 218
extends outwardly and in which the distance separating distal tip
210 and proximal end 212 of the plication head is decreased. As
shown as a transparent element in the bottom plan view of FIG. 38A
and the end view of FIG. 38B, a membrane or shroud 215 covers the
hinge members 214 and is connected to the distal tip 210 and
proximal portion 212 of the plication head 202 to form a vacuum
chamber 217. An opening 219 in the shroud positionable in contact
with stomach wall tissue to allow tissue to be drawn into the
chamber during use. Shroud 215 is preferably formed of silicone,
elastomeric material, or any other inelastic or elastic flexible or
deformable biocompatible material capable of forming a vacuum
chamber.
Referring to FIG. 37A, the proximal portion 212 of the plication
head 202 includes a hydraulic chamber 220. The hydraulic chamber
220 is fluidly coupled by a fluid line 222 to a source of fluid
224. An outer piston 226 is disposed within the hydraulic chamber
220. In the illustrated embodiment, piston 226 is a hollow cylinder
having a rear wall 228 and a front wall 230. Front wall 230
includes a center cutout 232. An inner piston 234 is disposed
within the outer piston 226, and includes a longitudinal plunger
236 extending through the cutout 232.
Each of the proximal hinge plates 216b includes an
inwardly-extending camming surface 238. The hinge plates include
proximal pivots 240 such that distally-oriented pressure against
camming surfaces 238 causes the hinge plates 216b to pivot about
the pivots 240 into the position shown in FIG. 37B.
Proximal portion 212 of the plication head 202 includes a staple
cartridge 242 containing staples arranged in an annular arrangement
(not visible in the drawing), and a staple driver 244 positioned to
drive staples from the distal end of the cartridge 242 when it is
advanced in a distal direction into contact with the staples.
Staple driver 244 may include a tissue penetrating element 248
(FIG. 40B) sufficiently sharp to form a hole in tissue.
An anvil 246 on the distal tip 210 is positioned to receive the
prongs of staples driven by staple driver 242 and to fold the
prongs into a closed position. Staple cartridge and anvil
arrangements are well known in the surgical and endoscopic stapling
art and need not be discussed in further detail. The staples (and
sutures) described for use herein may be permanent or
bioerodible/biodegradable.
Exemplary Method for Using the Third Preferred Embodiment
As with the previously discussed methods, a method of using the
plication system 200 of the third embodiment is carried out under
visualization using an endoscope advanced via the esophagus into
the stomach.
In preparation for use, the plication head is positioned with the
hinge members 214 in the streamlined position shown in FIGS. 36A
and 37A. The plication head 202 is introduced transorally into the
stomach, through an introducer sheath if needed to ensure smooth
passage through the esophagus. Pullwires 208 are manipulated to
orient the plication head 202 so that the opening 219 in the vacuum
chamber 217 (FIGS. 38 and 39) is positioned in contact with stomach
wall tissue at a location at which a plication is to be formed.
Next, as shown in FIG. 37B, hydraulic fluid is injected from fluid
source 224 into chamber 220. The fluid pressure advances outer
piston 226 in a distally direction, causing the front wall 230 of
the piston 226 to contact the camming surfaces 238, thus pivoting
the pivot plates 216b about proximal pivots 240. In response, hinge
members 214 pivot as shown in FIG. 37B until they reach the
partially expanded position shown in FIG. 37B. The vacuum source
206 is activated to create a vacuum which draws a pinch of tissue
into the vacuum chamber 217, with serosal tissue surfaces generally
facing one another as has been described with the other embodiments
(see e.g. FIG. 34B). The flexible nature of the shroud forming the
vacuum chamber 217 allows the vacuum chamber 217 to deform
outwardly as tissue is drawn into the chamber.
Once tissue is drawn in to the vacuum chamber 217, additional fluid
is directed into the hydraulic chamber 220 to advance the outer
piston 226 until the hinge members 214 are in the fully expanded
position shown in FIG. 37C. Expansion of the hinge members 214
draws the distal tip 210 towards the proximal portion 212 of the
plication head 202. This compresses the tissue within the vacuum
chamber 217, bringing the opposed serosal tissue surfaces into
contact or close proximity with each other similar to the tissue
positions shown in FIG. 34E. Once the tissue is compressed, staples
from the cartridge 242 are fired through the tissue by passing the
staple pusher 244 through the staple cartridge 242. If the staple
pusher 244 is provided with a tissue penetrating element 248 as
shown in FIG. 40B, the tissue penetrating element 248 penetrates
the opposed layers of stomach wall tissue as the staples are driven
through the tissue, forming a hole surrounded by an annular pattern
of staples.
The staples fold against the anvil 246. After stapling, the hinge
members are moved to the collapsed position shown in FIG. 36A. The
plicator is separated from the tissue and withdrawn from the body.
The tapered profile of the proximal portion 212 of the plication
head 202 allows the plication head 202 to pass through the
gastro-esophageal junction, esophagus, and mouth with minimal
trauma.
In the illustrated embodiment, the staple pusher 244 is driven by
the injection of hydraulic fluid into the cylindrical piston 226.
The fluid drives plunger 236 distally into contact with the staple
pusher 244, which in turns drives through the cartridge 242 to
advance the staples. FIG. 40A illustrates one arrangement of the
pistons 226, 234 within the hydraulic chamber 220 that will allow
this to be achieved. As shown, hydraulic cylinder 220 includes
first and second inlets I1 and I2, and the piston 226 includes a
third inlet 13. O-ring seals O1, O2 are positioned on the exterior
surface of piston 226 and o-ring seals O3 and O4 are positioned on
the exterior surface of the inner piston 234. When hydraulic
pressure is applied to I1, the piston 226 advances distally
(towards the left in the view shown) to expand the hinge members
214 (FIG. 37C) and compress the tissue as discussed above. After
o-ring seal O2 has moved distally of inlet I2, fluid pressure can
be directed through I2 and into I3, causing inner piston 234 to be
driven distally to advance the staple pusher 244 (FIG. 37A).
Although in the FIG. 40A embodiment the hydraulics for tissue
compression and stapling and combined on the proximal side of the
plication head, these functions may be separated, with the
hydraulics driving one function positioned distally of the vacuum
chamber and the hydraulics driving the other function positioned
proximally of the vacuum chamber.
FIGS. 41A and 41B are side elevation views of a modified plication
head 202c in which the distal and proximal portions 210c, 212c are
coupled by a hinge 214c that is actuated by a lead screw 211. Lead
screw is extended as shown in FIG. 41A to elongate the plication
head 202c for passage into the body and for expansion of the vacuum
chamber which, as with the FIG. 36A embodiment, is defined by a
shroud 215 (FIG. 41C). Once tissue is drawn into the chamber, the
lead screw 211 is actuated to bring the distal and proximal
portions 210c, 212c into alignment for compression and stapling of
the tissue as described above.
Plication Reinforcements
Reinforcements of various types may be implanted in or on
plications formed using the plication system. Such reinforcements
may function to reinforce the staple array, help to more evenly
distribute the forces applied to the tissue by the staples, and/or
facilitate bonding between the opposed serosal layers. Suitable
reinforcements include ones positionable on or between the serosal
tissue layers ("serosal side reinforcements"), as well as those
delivered on the side of the mucosal tissue ("mucosal side
reinforcements").
Serosal side reinforcements have been discussed in connection with
the first and second embodiments. A reinforcement similar to mesh
element 24 described in connection with FIGS. 14A, 14B may serve as
a permanent or semi-permanent implant that will reinforce the
staple array applied to the tissue and/or facilitate serosal tissue
bonding between the layers of stomach wall tissue that are to be
stapled or sutured together. For this purpose, the material may be
a synthetic or non-synthetic mesh (formed of nitinol, polyester, or
other natural or synthetic material), porous or non-porous
material, slotted material, or any other material through which
adhesions will form or onto which tissue will grow. Examples
include, but are not limited to, polypropylene, materials sold
under the trade names Goretex or Dacron, or tissue graft material
such as the Surgisis material sold by Wilson Cook Medical, Inc. The
material may be treated with tissue-ingrowth promoting substances
such as biologics.
In an alternative embodiment of a serosal side reinforcement shown
in FIGS. 42A and 42B, a reinforcement 270 (which may be formed of a
polyester fabric, mesh, or any other material including those
listed elsewhere in this application) is carried by a frame 272
having a plurality of outwardly extending arms that spring to an
expanded position when released from a hollow tube. The tube might
be any of the tubes described above for delivering mesh or
sclerosing agents etc. to the serosal tissue, e.g. tube 50g of FIG.
34A. The hollow tube 274 is passed through stomach wall tissue so
that its distal end is positioned between serosal layers (e.g., the
position of needle 50a in FIG. 26B). The frame 272 is advanced out
the distal end of the needle to allow the arms of the frame to
spread to the expanded position shown, thereby expanding the
reinforcement between the opposed serosal layers. The reinforcement
is fixed between the layers by the staples driven through the
opposed regions of stomach wall, and the frame is withdrawn from
the needle and out of the body.
Mucosal side reinforcements may take the form of reinforcements
that are positioned on or adjacent to one or both of the mucosal
surfaces lining the "pinch" of tissue that will form the plication.
These reinforcements may be features of the staples or staple
arrays, or they may be separate components engaged by staples as
the staples are advanced through the tissue.
Referring to FIG. 43A, conventional stapling procedures will often
include two parallel rows of staples, in which the staples in one
row are laterally offset from the staples of the other row.
According to the disclosed method, it is useful to employ this
technique to the circular staple pattern delivered using the
plicators described above, to produce two concentric rings of
offset staples 276, as shown in FIG. 43B. It has been found to be
additionally beneficial to form mucosal side reinforcements by
linking or interlocking the staples to provide greater structural
reinforcement to the stapled tissue and/or to more evenly
distribute forces applied to the tissue by the staples. Linked
staple arrays may be formed by arranging the staples 276 in the
cartridge of the plicator in a single circular pattern to interlock
as shown in FIG. 43C, or in a double circular pattern with two
concentric rings of interlocked staples. The staples 276a may be
curvilinear so as to form a locking pattern shown in perspective
view of FIG. 43D. A linear arrangement of staples 276 may also be
linked as shown in FIG. 43E.
In alternative embodiments, staples are linked together by
reinforcing members formed of metallic or polymeric materials, such
as nitinol, titanium, stainless steel PEEK, or other biocompatible
materials including those that are bioerodible/biodegradable.
According to these embodiments, the reinforcing members are
positioned on one or both of the mucosal sides of the "pinch" of
tissue engaged by the plication system such that they are captured
by staples being driven through the tissue. In a preferred
embodiment, the staples capture a cartridge side reinforcing ring
278 (FIG. 13A) as they leave the cartridge and capture an anvil
side reinforcing ring 280 (FIG. 44B) as the anvil shapes and bends
them. Upon completion of the plication, the staples are linked to
one another so that they cannot separate or expand radially. The
rings promote even distribution of forces around the ring of
staples.
The reinforcing rings are preferably provided separate from the
staples although they instead may be integral with the staples. In
the illustrated embodiment, ring 280 is positioned against the
staple anvil 246 as shown in FIG. 45A. Ring 278 is seated within
the cartridge 242 (FIG. 45B), with the staples 276 aligned with
their prongs 282 extending through a plurality of the loops 284 in
the ring 278. When staples 276 are driven from the cartridge, they
capture ring 278 against the adjacent mucosal tissue as shown in
FIG. 46A. The staple legs/prongs 282 pass through the stomach wall
tissue into contact with the indentations 286 of the anvil 246.
When they contact the anvil 246, the prongs 282 fold around the
staple ring 280 to capture the ring 280 and interlock the staples
on the anvil side of the plication as shown in FIG. 46B. Rings or
other interlocking elements of this type may be used with single-
or double-staple row configurations.
Rings 278, 280 are shown as generally circular, although
alternative reinforcements of different shapes and patterns may
also be used, including those shaped to accommodate linear, oval
and other staple patterns.
Applications for Cutout Plications
FIGS. 47A through 49 illustrate examples of applications for cutout
plications formed within the stomach using any methods or system,
including those described above. As shown, the cutout plications
can eliminate the need for anchor loops of the type described in
connection with the first embodiment. Each of these applications is
preferably (but optionally) performed in a separate procedure from
that in which the plications are formed, so as to allow serosal
bonding to occur before the plicated tissue is subjected to
stresses imparted by implants and/or further manipulation.
A first application shown in FIGS. 47A through 47C uses two or more
cutout plications CP, preferably formed at the gastro-esophageal
junction region of the stomach. According to this application, the
cutouts C of the plications are brought into partial or full
alignment with one another (FIGS. 47A and 47B) using an endoscope
or another endoscopic instrument. A restrictive implant such as the
implant 4 shown in FIG. 4 is threaded through the aligned cutouts
while in a radially-collapsed position, and is then allowed to
expand to the position shown in FIG. 47C. Instruments and methods
for orienting and expanding an implant of this type are shown and
described in U.S. application Ser. No. 11/439,461, filed May 23,
2006. Once in place, the implant greatly reduces the amount of food
a patient can consume, by slowing the rate at which food can
descend from the esophagus into the stomach.
In the method shown in FIG. 48A, multiple cutout plications CP are
formed in select positions allowing the plications to be drawn
together so as to significantly narrow the channel through which
food can pass through the stomach. For example, the plications CP
of FIG. 48A are arranged such that manipulating the plications to
place their cutouts C in alignment causes the plications themselves
to form a barrier against passage of food. This arrangement limits
most food flow to a narrow food passage FP and creates a gastric
pouch GP adjacent to the food passage. An implant 4a is positioned
within the cutouts C as described above to retain the plications CP
in their gathered arrangement. The implant 4a may have a similar
configuration to the implant 4 of FIG. 4, including a through-hole
allowing some passage of food through the implant, or it may be
impenetrable by food thus forming a plug largely preventing passage
of food and gastric juices through the cutouts C. The implant may
include a valve oriented to minimize restriction of food flow out
of the stomach during vomiting. Other implants that will retain the
gathered configuration of the plications CP may alternatively be
used, including lengths of biocompatible material passed through
the cutouts and knotted or otherwise fastened into loops. In other
embodiments, the collective sizes and numbers of the plications may
themselves be sufficient to restrict flow of food into the stomach,
without the need for any implants to connect them to one
another.
In either embodiment, if the implant 4, 4a is to be removed or
replaced with an implant of different dimensions (e.g. so as to
slow the rate of weight loss following a period of significant
weight loss, or to increase the rate of weight loss), endoscopic
instruments may be used to withdraw the implant from the cutouts C
and to remove the implant from the stomach.
In another embodiment shown in FIG. 49, a restrictive pouch 4b may
include anchors 5 that are inserted into cutout plications CP.
Anchors 5 are shown as having a button shape, but they may
alternatively be other structures including loops that close on
themselves to prevent detachment from the cutout, or they might be
legs of the type disclosed in WO 2005/037152.
As is evident from above, the disclosed endoscopic systems function
to draw a tissue into the stomach to form a depression on the
exterior surface of the stomach, and staple (or suture, or fasten
or adhere etc) the opposed stomach wall sections lining the
depression together another to form a plication. The system may
additionally place material of a type that will promote strong
tissue adhesion within the depression (on the exterior of the
stomach) and retain the material between the serosal surfaces to
enhance. Additionally or alternatively, mucosal reinforcements such
as structures that interconnect the staples may be implanted. While
these systems provide convenient embodiments for carrying out this
function, there are many other widely varying instruments or
systems may alternatively be used within the scope of the present
invention. Moreover, the disclosed embodiments may be combined with
one another in varying ways to produce additional embodiments.
Thus, the embodiments described herein should be treated as
representative examples of systems useful for forming endoscopic
tissue plications, and should not be used to limit the scope of the
claimed invention.
Any and all patents, patent applications and printed publications
referred to above, including those relied upon for purposes of
priority, are incorporated herein by reference.
* * * * *